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Work on the revision of Poland’s pharmaceutical reimbursement law is ongoing. Government officials and industry representatives have already held intensive discussions on the matter, and a final draft of the amendment is expected to be released by the end of this summer.
Leaders of the Department of Drug Policy and Pharmacy at the Ministry of Health met with the pharmaceutical industry to present plans to revise the reimbursement law.
“A few weeks ago we had the opportunity to submit our comments and suggestions (…) We were met with a very open and substantive dialogue by the Ministry of Health,” Michał Byliniak, General Manager of INFARMA, told Euractiv.
He added: “These are open and constructive discussions aimed at developing regulations that streamline the reimbursement process, taking into account the industry’s experience and capabilities.”
The 80th Amendment
The Polish Reimbursement Act was amended last year. This was the first major amendment to the law since 2012. However, some provisions of the Major Amendment to the Reimbursement Act (DNUR) were not well received by the pharmaceutical industry.
So the Ministry of Health began to make changes.
Director of the Department of Drug Policy and Pharmacy Katarzyna Piotrowska-Radziewicz and her deputy Mateusz Oczkowski reported that nearly 270 comments were submitted during the pre-consultation period.
Ultimately, 80 amendments were proposed to the reimbursement law.
As Katarzyna Piotrowska-Radziewicz emphasizes: “For the Ministry of Health, the starting point for the revision is to ensure patients’ access to medicines.”
The final draft is expected to be ready by the end of summer, with internal consultation scheduled for September. A public consultation will follow. “We plan to roll out the changes this year,” assures Mateusz Oczkowski.
Proposed changes
One of the key issues the ministry hopes to address is the complex process of applying for reimbursement. The ministry intends to simplify this process by introducing more transparent and efficient procedures. One of the reforms will be to expand patient access to biologic treatments.
Another reform the Ministry of Health hopes to introduce is the definition of rare diseases. At the same time, there are plans to introduce a separate reimbursement pathway for drugs used to treat rare diseases. This is expected to significantly increase the availability of medical technologies for rare diseases.
In addition, the Department of Health wants patients to have faster access to new treatments that are reimbursed by drug plans.
The Ministry of Health has also decided to withdraw a controversial clause in the Major Reimbursement Law Amendment Bill introduced last year that allowed reimbursement of over-the-counter medicines.
The Ministry of Health wants to scrap the requirement to distribute shortage drugs equally to Poland’s top 10 pharmaceutical wholesalers. The removal of this requirement is intended to facilitate drug distribution and reduce logistics costs.
In addition, the Ministry of Health announced changes to the subsidy limits for pharmaceutical raw materials used in the preparation of prescription drugs. The pharmaceutical industry demanded that these limits be completely lifted and the old rules for prescription drug reimbursement be restored. The Ministry of Health disagreed with these changes but suggested increasing the subsidy limits.
Cautious optimism
The Ministry of Health’s proposed changes to the reimbursement law have been met with cautious optimism by the pharmaceutical industry.
“We have seen some new regulations that we believe, if drafted properly, could speed up the reimbursement process and shorten the time from registration to getting the drug to patients. At this point, I can say we are cautiously optimistic, but the key is to see the actual draft of the law,” Byliniak said.
“It is only during the external consultation phase that we will be able to discuss the proposals in detail. At this point, we have not identified any issues that require intervention,” he said.
Mikołaj Konstanty, deputy chairman of the Supreme Medicines Council, stressed that the Ministry of Health’s proposal shows that this is indeed a comprehensive amendment.
“This is certainly a very important project. Some changes may be important for pharmacists, so we need to review and analyze it thoroughly as a community, together with lawyers. There are issues that need clarification. We are waiting for the draft itself to be able to respond to this substantively,” Mikołaj Konstanty concluded “Health Manager”.
(Author: Paulina Mozolewska; Editors: Vasiliki Angouridi, Brian Maguire | Euractiv Advocacy Lab)
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